# Manage Risk Measures Learn how to manage core and local risk measures for your _Risk Management Plans_. ## About Risk Measures A risk measure is an element of a product's RMP that identifies a specific risk to be tracked, managed, and measured. Risk measures are created from within an existing _Risk Management Plan_ and are defined as either _Core Risk Measures_ or _Local Risk Measures_. ## Overview This article explains how to: - [Create _Core Risk Measures_][0] - [Create _Local Risk Measures_][1] ## Prerequisite To use _Risk Measures_, your Admin must configure your Vault for Risk Management. ## Create Core Risk Measures To create the risk measures for a _Core Risk Management Plan Version_: 1. Navigate to **Risk Management > Core RMPs > [Core RMP]**. 2. In the _Core RMP Versions_ section, select the required **Core RMP Version** record. This is usually the latest version. 3. In the _RMP Risks_ section, select the required **RMP Risk** record. 4. In the _Risk Measures_ section, create a record for each risk measure associated with the selected _RMP Risk_ record: 1. Select **Create** and in the _Create RMP Risk Measure_ window, select **Core Risk Measure**. 2. Complete the [_Core Risk Measure_ fields][4]. 3. Select **Save**. 4. In the _Documents_ section of the _Core Risk Measure_ record, upload any related documents for the _Risk Measure_ using the standard document creation process. Use the _Risk Management > Risk Measure > Risk Measure Tool_ document type. 5. Repeat steps 3 and 4 to create risk measures for each additional _RMP Risk_ record. ### Core Risk Measure Fields

Field	Description
Name	Vault populates this field automatically.
Minimized Risk	Select the RMP Risk for the Core Risk Measure.
Indication	Select the MedDRA term for the indication.
Routine/Additional	Select whether the Core Risk Measure is Routine or Additional.
Measure Category	Select the type of risk minimization measure. The options available depend on the selection you made for the Routine/Additional field.
Measure Sub-Category	If you defined this Core Risk Measure as Additional, select the appropriate sub-category. The options available depend on the selection you made for the Measure Category field. Note: If you selected Pregnancy Prevention Programmes, no sub-categories are available.
Core Implementation Strategy	Select the Core Implementation Strategy for the Core Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search. If the drop-down is blank, you must first create a Core Implementation Strategy.
Version	Enter the applicable version number for the Core Risk Measure.
Based On	If applicable, select the Risk Measure record on which this Core Risk Measure record is based.
Planned Start Date	Enter the Risk Measure's expected start date. Use the calendar to select the date or enter the date manually.
Actual Start Date	Enter the actual date the Risk Measure came into force. Use the calendar to select the date or enter the date manually.
Actual End Date	Enter the actual date the Risk Measure ended. Use the calendar to select the date or enter the date manually.

## Create Local Risk Measures When the _Create Local RMPs_ action creates _Local Risk Management Plan Version_ records, these records inherit a copy of the _Risk Measure_ records from their parent _Core Risk Management Plan Version_. If required, complete the following steps to create additional _Local Risk Measure_ records for a _Local Risk Management Plan Version_: 1. Navigate to **Risk Management > Local RMPs > [Local RMP]**. 2. In the _Local RMP Versions_ section, select the required **Local RMP Version** record. This is usually the latest version. 3. In the _Local Risks_ section, select the required **Local RMP Risk** record. 4. In the _Risk Measures_ section, create a record for each risk measure associated with the selected _Local RMP Risk_ record: 1. Select **Create** and in the _Create RMP Risk Measure_ window, select **Local Risk Measure**. 2. Complete the [_Local Risk Measure_ fields][2]. 3. Select **Save**. 4. In the _Documents_ section of the _Local Risk Measure_ record, upload any related documents for the _Risk Measure_ using the standard document creation process. Use the _Risk Management > Risk Measure > Risk Measure Tool_ document type. 5. In the _Risk Measure Tracking_ section, select **Create** and complete the [_RMP Risk Measure Tracking_ fields][3]. 6. Select **Save**. 7. Navigate back to the _Local Risk Measure_ record using the **[Local Risk Measure]** link at the top of the page. 5. Repeat steps 3 and 4 to create _Local Risk Measure_ records for each additional _RMP Risk_ record. ### Local Risk Measure Fields

Field	Description
Name	Vault populates this field automatically.
Minimized Risk	To populate this field, you must first populate the RMP and RMP Version fields. Select the Minimized Risk value for the Local Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Minimized Local Risk	If Vault does not populate this field automatically, you may select the specific risk that this measure will help to minimize in the local market from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Indication	Select the MedDRA term for the indication.
Routine/Additional	Select whether the Local Risk Measure is Routine or Additional.
Measure Category	Select the type of risk minimization measure. The options available depend on the selection you made for the Routine/Additional field.
Measure Sub-Category	If you defined this Local Risk Measure as Additional, select the appropriate sub-category. The options available depend on the selection you made for the Measure Category field. Note: If you selected Pregnancy Prevention Programmes, no sub-categories are available.
Core Risk Measure	Select the Core Risk Measure on which this Local Risk Measure is based from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Market	Select the Country to which this Local Risk Measure applies from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Local Disposition	Select how the Local Risk Measure will be used in the applicable region: Core As Is: Use the Local Risk Measure in the same way as the Core Risk Measure. Core Modified: Use the Local Risk Measure in the same way as the Core Risk Measure, but with some modifications. Country Specific: Use the Local Risk Measure in a way that is specific to the applicable Country. Not Applicable: The Local Risk Measure is not applicable to this region.
Version	Enter the applicable version number for the Local Risk Measure.
Based On	If applicable, select the Risk Measure record on which this Local Risk Measure record is based from the drop-down or select the Advanced Search () icon to use filters and refine your search.
RMP	Select the RMP for the Core Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search.
RMP Version	Select the RMP Version for the Core Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Local RMP	Vault populates this field automatically.
Local RMP Version	Vault populates this field automatically.
Core Implementation Strategy	Select the Core Implementation Strategy for the Core Risk Measure from the drop-down or select the Advanced Search () icon to use filters and refine your search. If the drop-down is blank, you must first create a Core Implementation Strategy.
Local Implementation Strategy	Select the Local Implementation Strategy that covers the development of this minimization tool from the drop-down or select the Advanced Search () icon to use filters and refine your search.
HA Submission Date	Enter the date the Risk Measure was submitted to the health authority for endorsement. Use the calendar to select the date or enter the date manually.
HA Endorsement Date	Enter the date the Risk Measure was endorsed by the health authority for use. Use the calendar to select the date or enter the date manually.
Planned Start Date	Enter the Risk Measure's expected start date. Use the calendar to select the date or enter the date manually.
Actual Start Date	Enter the actual date the Risk Measure started. Use the calendar to select the date or enter the date manually.
Actual End Date	Enter the actual date the Risk Measure ended. Use the calendar to select the date or enter the date manually.

### RMP Risk Measure Tracking Fields

Field	Description
Target Date	Enter the target date for distribution of the Risk Measure. Use the calendar to select the date or enter the date manually.
Target Completion Date	Enter the expected tracking period end date for the Risk Measure. Use the calendar to select the date or enter the date manually.
Target Value	Enter the target numeric outcome of the Risk Measure.
Outcome Verdict	Select the evaluation of the actual outcome of the Risk Measure: Target Met Target Missed Target Cancelled
Channel	Enter the distribution channel for the Risk Measure.
Actual Date	Enter the date that the outcome of the Risk Measure was recorded. Use the calendar to select the date or enter the date manually.
Actual Completion Date	Enter the date that the tracking period of the Risk Measure ended. Use the calendar to select the date or enter the date manually.
Actual Value	Enter the actual outcome of the Risk Measure.

[0]: #create-core-risk-measures [1]: #create-local-risk-measures [2]: #local-risk-measure-fields [3]: #rmp-risk-measure-tracking-fields [4]: #core-risk-measure-fields